Apparatus for dermatological treatment and fractional skin resurfacing

ABSTRACT

A system and method for performing fractional resurfacing of a target area of skin using electromagnetic radiation are provided. An electromagnetic radiation is generated by an electromagnetic radiation source. The electromagnetic radiation is caused to be applied to a particular portion of a target area of skin. The electromagnetic radiation can be impeded from affecting another portion of the target area of the skin by a mask. Alternatively, the electromagnetic radiation may be applied to portions of the target area of the skin, other than the particular portion.

CROSS REFERENCE TO RELATED APPLICATIONS

This present application application is a divisional of U.S. applicationSer. No. 11/780,261 filed on Jul. 19, 2007 that is issuing as U.S. Pat.No. 9,351,792 on May 31, 2016, which is a continuation of U.S.application Ser. No. 10/542,390 filed on Jul. 13, 2005, and claimspriority from International Application No. PCT/US2004/009452 filed onMar. 25, 2004, which claims priority from U.S. Provisional PatentApplication Ser. No. 60/458,770, filed Mar. 27, 2003, the disclosures ofwhich are incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to methods and apparatus that useelectromagnetic radiation for dermatological treatment and, moreparticularly to a method and apparatus that use optical radiation toablate or damage a target area of skin surface for dermatologicaltreatment, which skin surface includes the epidermis and parts of thedermis as the objective or side effect of the desired treatment.

2. Background Art

There is an increasing demand for repair of or improvement to skindefects, which can be induced by aging, sun exposure, dermatologicaldiseases, traumatic effects, and the like. Many treatments which useelectromagnetic radiation have been used to improve skin defects byinducing a thermal injury to the skin, which results in a complex woundhealing response of the skin. This leads to a biological repair of theinjured skin.

Various techniques providing this objective have been introduced inrecent years. The different techniques can be generally categorized intwo groups of treatment modalities: ablative laser skin resurfacing(“LSR”) and non-ablative collagen remodeling (“NCR”). The first group oftreatment modalities, i.e., LSR, includes causing thermal damage to theepidermis and/or dermis, while the second group, i.e., NCR, is designedto spare thermal damage of the epidermis.

LSR with pulsed CO₂ or Er:YAG lasers, which may be referred to in theart as laser resurfacing or ablative resurfacing, is considered to be aneffective treatment option for signs of photo aged skin, chronicallyaged skin, scars, superficial pigmented lesions, stretch marks, andsuperficial skin lesions. However, patients may experience majordrawbacks after each LSR treatment, including edema, oozing, and burningdiscomfort during first fourteen (14) days after treatment. These majordrawbacks can be unacceptable for many patients. A further problem withLSR procedures is that the procedures are relatively painful andtherefore generally require an application of a significant amount ofanalgesia. While LSR of relatively small areas can be performed underlocal anesthesia provided by injection of an anestheticum, LSR ofrelatively large areas is frequently performed under general anesthesiaor after nerve blockade by multiple injections of anesthetic.

Any LSR treatment results in thermal skin damage to the treatment areaof the skin surface, including the epidermis and/or the dermis. LSRtreatment with pulsed CO₂ lasers is particularly aggressive, causingthermal skin damage to the epidermis and at least to the superficialdermis. Following LSR treatment using CO₂ lasers, a high incidence ofcomplications can occur, including persistent erythema,hyperpigmentation, hypopigmentation, scarring, and infection (e.g.,infection with Herpes simplex virus). LSR treatment with the Er:YAGlaser has been introduced as a more gentle alternative to the CO₂ laser,due to the lesser penetration depth of the Er:YAG pulsed laser. Usingthe Er:YAG laser results in a thinner zone of thermal injury within theresidual tissue of the target area of the skin. However, LSR that usesthe Er:YAG laser produces side effects similar to those made by LSR thatuses the CO₂ laser within the first days after treatment.

A limitation of LSR using CO₂ or Er:YAG lasers is that ablative laserresurfacing generally can not be performed on the patients with darkcomplexions. The removal of pigmented epidermis tissue can cause severecosmetic disfigurement to patients with a dark complexion, which maylast from several weeks up to years, which is considered by mostpatients and physicians to be unacceptable. Another limitation of LSR isthat ablative resurfacing in areas other than the face generally have agreater risk of scarring. LSR procedures in areas other than the faceresult in an increased incidence of an unacceptable scar formationbecause the recovery from skin injury within these areas is not veryeffective.

In an attempt to overcome the problems associated with LSR procedures, agroup of NCR techniques has emerged. These techniques are variouslyreferred to in the art as non-ablative resurfacing, non-ablativesubsurfacing, or non-ablative skin remodeling. NCR techniques generallyutilize non-ablative lasers, flashlamps, or radio frequency current todamage dermal tissue while sparing damage to the epidermal tissue. Theconcept behind NCR techniques is that the thermal damage of only thedermal tissues is thought to induce wound healing which results in abiological repair and a formation of new dermal collagen. This type ofwound healing can result in a decrease of photoaging related structuraldamage. Avoiding epidermal damage in NCR techniques decreases theseverity and duration of treatment related side effects. In particular,post procedural oozing, crusting, pigmentary changes and incidence ofinfections due to prolonged loss of the epidermal barrier function canusually be avoided by using the NCR techniques.

Various strategies are presently applied using nonablative lasers toachieve damage to the dermis while sparing the epidermis. Nonablativelasers used in NCR procedures have a deeper dermal penetration depth ascompared to ablative lasers used in LSR procedures. Wavelengths in thenear infrared spectrum can be used. These wavelengths cause thenon-ablative laser to have a deeper penetration depth than the verysuperficially-absorbed ablative Er:YAG and CO₂ lasers. The dermal damageis achieved by a combination of proper wavelength and superficial skincooling, or by focusing a laser into the dermis with a high numericalaperture optic in combination with superficial skin cooling. While ithas been demonstrated that these techniques can assist in avoidingepidermal damage, one of the major drawbacks of these techniques istheir limited efficacies. The improvement of photoaged skin or scarsafter the treatment with NCR techniques is significantly smaller thanthe improvements found when LSR ablative techniques are utilized. Evenafter multiple treatments, the clinical improvement is often far belowthe patient's expectations. In addition, clinical improvement is usuallyseveral months delayed after a series of treatment procedures.

Another limitation of NCR procedures relates to the breadth ofacceptable treatment parameters for safe and effective treatment ofdermatological disorders. The NCR procedures generally rely on anoptimum coordination of laser energy and cooling parameters, which canresult in an unwanted temperature profile within the skin leading toeither no therapeutic effect or scar formation due to the overheating ofa relatively large volume of the tissue.

Yet another problem of non-ablative procedures relates to the sparing ofthe epidermis. While sparing the epidermis is advantageous in order todecrease the side effects related to complete removal of the epidermis,several applications of NCR procedures may benefit from at least partialremoval of epidermal structures. For example, photoinduced skin agingmanifests not only by the dermal alterations, but also by epidermalalterations.

A further problem of both ablative and nonablative resurfacing is thatthe role of keratinocytes in the wound healing response is notcapitalized upon. Keratinocyte plays an active role in the wound healingresponse by releasing cytokines when the keratinocyte is damaged. Duringtraditional ablative resurfacing procedures, the keratinocytes areremoved from the skin along with the epidermis, thereby removing themfrom the healing process altogether. On the other hand, in traditionalnon-ablative procedures, the keratinocytes, which are located in theepidermis, are not damaged, therefore they do not release cytokines toaid in the healing process.

Another major problem with all LSR and NCR techniques now used is theappearance of visible spots and/or edges after treatment due toinflammation, pigmentation, or texture changes, corresponding to thesites of treatment. Devices for LSR and NCR produce macroscopic (easilyseen) sexposure areas. For example, laser exposure spot diameterstypically vary from about 1 to 10 mm, and NCR exposure spot diametersfrom about 3 to 50 mm. Some devices, such as indense pulsed lightdevices, leave “boxes” of skin response due to rectangular outputpatterns on the skin. Patients do not like such spot or box patterns,easily seen as red, brown or white areas ranging from on the order ofmillimeters to centimeters in size, which remain for days or even yearsafter treatment.

Therefore, there is a need to provide a procedure and apparatus thatcombine safe and effective treatment for improvement of dermatologicaldisorders with minimum side effects, such as intra proceduraldiscomfort, post procedural discomfort, lengthy healing time, and postprocedural infection.

SUMMARY OF THE INVENTION

It is therefore one of the objects of the present invention to providean apparatus and method that combines safe and effective treatment foran improvement of dermatological disorders with minimum side effects.Another object of the present invention is to provide an apparatus andmethod that cause thermal skin damage to only a fraction of a targetarea of skin.

These and other objects can be achieved with the exemplary embodiment ofthe apparatus and method according to the present invention, in whichportions of a target area to be subjected to irradiation are masked. Theexemplary apparatus can include at least one shielding member configuredto mask at least one portion of a target area of skin fromelectromagnetic radiation, in which the shielding members are formedsuch that a minimal amount of electromagnetic radiation is reflectedback towards an electromagnetic radiation source.

In another advantageous embodiment of the present invention,electromagnetic radiation can be generated by an electromagneticradiation source, thus causing the electromagnetic radiation to beapplied to a target area of the skin. At least one portion of the targetarea of the skin is then masked from the electromagnetic radiation usinga mask.

In yet another advantageous embodiment of the present invention, anapparatus and method for treating dermatological conditions is provided.In particular, a delivery module and translator are utilized. Thedelivery module is configured to direct electromagnetic radiationgenerated by an electromagnetic radiation source to a predetermined areawithin a target area of skin, wherein the predetermined area is locatedin a location relative to the delivery module, and wherein theelectromagnetic radiation is adapted to cause thermal damage toepidermal tissue and dermal tissue of the predetermined area within thetarget area of the skin. The translator is capable of moving thedelivery module, such that the delivery module targets a plurality ofspatially separated individual exposure areas of the predetermined area.

In a further advantageous embodiment of the present invention, theelectromagnetic radiation can be applied to a first individual exposurearea of the target area of the skin. The electromagnetic radiation canthen be applied to a second individual exposure area of the target areaof the skin, which is separated from the first individual exposure areaby a non-irradiated skin section.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention and itsadvantages, reference is now made to the following description, taken inconjunction with the accompanying drawings, in which:

FIGS. 1A-1C show progressive illustrations of a first exemplaryembodiment of a fractional resurfacing system for conducting variousdermatological treatments at various stages of use according to thepresent invention;

FIG. 2 shows a top view of a first exemplary embodiment of a maskaccording to the present invention;

FIG. 3 shows a cross-sectional view of the mask of FIG. 2;

FIG. 4 shows a top view of a second exemplary embodiment of the maskaccording to the present invention;

FIG. 5 shows a cross-sectional view of the mask of FIG. 4;

FIG. 6 shows a cross-sectional view of another variant of the mask ofFIG. 4;

FIGS. 7A and 7B show progressive illustrations of a second exemplaryembodiment of the fractional resurfacing system for conducting variousdermatological treatments at various stages of use according to thepresent invention;

FIG. 8 shows a top view of small individual exposure areas created bythe fractional resurfacing system of FIGS. 7A and 7B; and

FIG. 9 shows an exemplary embodiment of a system for monitoring thelocation of the fractional resurfacing system of FIGS. 7A and 7B.

Throughout the drawings, the same reference numerals and characters,unless otherwise stated, are used to denote like features, elements,components, or portions of the illustrated embodiments. Moreover, whilethe present invention will now be described in detail with reference tothe Figures, it is done so in connection with the illustrativeembodiments.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIGS. 1A-9 illustrate various embodiments of a method and apparatus forfractional resurfacing of a target area of skin. Generally, theexemplary methods and apparatus deliver an electromagnetic radiation tothe patient's skin defined by various patterns, so as to induce thermalinjury of the skin surface corresponding to such patterns and involvingonly a fraction of the targeted surface area of the skin. Such techniquecombines the efficacy of ablative resurfacing procedures with theminimal side effects of non-ablative procedures. The delivery of theelectromagnetic radiation to the skin in a predetermined pattern isachieved by either masking parts of the target area of the skin surfacein order to protect the masked parts of the skin surface from theelectromagnetic radiation, or by utilizing a light beam of relativelysmall diameter which is scanned across the skin surface by various meansin order to generate a specific pattern for affecting superficialthermal skin injury.

Fractional resurfacing is defined as the controlled ablation, removal,destruction, damage or stimulation of multiple small (generally lessthan 1 mm) individual exposure areas of skin tissue with interveningspared areas of skin tissue, performed as a treatment to improve theskin. The individual exposure areas may be oval, circular, arced and/orlinear in shape. The spatial scale of fractional resurfacing is chosento avoid the appearance of various spots or boxes on a macroscopicscale, while still providing effective treatment because the multiplesmall areas can be exposed to greater than a minimal stimulus. Forexample, removal or photothermal destruction of thousands of 0.1 mmdiameter individual exposure areas, spaced 0.2 mm apart, and extendinginto the skin up to a depth of 0.5 mm, is well tolerated and produceseffective improvement of photoaging, without apparent spots and withrapid healing. Spared skin between the individual exposure areas rapidlyinitiates a wound healing response, which is better tolerated thanconventional LSR.

During the exemplary fractional resurfacing procedure of the presentinvention, certain portions of the target area remain undamaged, therebypreserving keratinocytes and melanocytes, which serve as a pool ofundamaged cells to promote reepithelialization. This procedure differsfrom the traditional resurfacing procedures, such that the entirety ofthe target area is damaged. In traditional resurfacing procedures,reepithelialization is generally initiated from the depth of anundamaged follicular epithelium. Because the traditional proceduresremove the entire epithelium, an important factor for the time ofreepithelialization is the density of follicles. The vellus hair densityof the face (439 hairs/cm²) of the subject is significantly higher thanon the back of the subject (85 hairs/cm²). Therefore, the face of thesubject, generally experiences better and faster reepithelization incomparison to other body areas with a lower hair density.

The resurfacing of the dark pigmented skin is currently not veryfrequently performed because of the prolonged repigmentation process.The fractional resurfacing technique improves the repigmentation processbut, melanocytes do not migrate well. By sparing certain portions of thetarget area of the skin, the travel distance of melanocytes can bedecreased, thereby reducing the repigmentation time and allowing theresurfacing of all skin types.

FIGS. 1A-1C illustrate a progressive use of a first exemplary embodimentof a fractional resurfacing system 100 for conducting variousdermatological treatments using electromagnetic radiation (“EMR”) andgenerating a superficial pattern of skin damage of a target area byusing a mask according to the present invention. The system 100 may beused for collagen remodeling, removal of unwanted pigment or tattoo,and/or other dermatological applications. As shown in FIGS. 1A-1C, thesystem 100 includes a case 101, a control module 102, an EMR source 104,delivery optics 106 and a mask 108. The case 101 contains the controlmodule 102, the EMR source 104, and the delivery optics 106. An apertureis provided through a sidewall of the case 101. The mask 108 is placedin registration with the aperture formed through the sidewall of thecase 101. By placing the mask 108 in registration with the aperture ofthe case 101, the focal length of the EMR emitted by the delivery optics106 is fixed, and can be configured such that it does not impact theside of the mask 108, so as to cause injuries to the operator of thefractional ablation system 100. The control module 102 is incommunication with the EMR source 104, which in turn is operativelyconnected to the delivery optics 106.

In one exemplary variant of the present invention, the control module102 can be in wireless communication with the EMR source 104. In anothervariant, the control module 102 may be in wired communication with theEMR source 104. In another exemplary variant of the present invention,the control module 102 can be located outside of the case 101. Inanother variant, the EMR source 104 is located outside of the case 101.In still another variant, the control module 102 and the EMR source 104are located outside of the case 101. It is also possible that the mask108 is not connected to the case 101.

The control module 102 provides application specific settings to the EMRsource 104. The EMR source 104 receives these settings, and generatesEMR based on these settings. The settings can control the wavelength ofthe EMR, the energy delivered to the skin, the power delivered to theskin, the pulse duration for each EMR pulse, the fluence of the EMRdelivered to the skin, the number of EMR pulses, the delay betweenindividual EMR pulses, the beam profile of the EMR, and the size of thearea within the mask exposed to EMR. The energy produced by the EMRsource 104 can be an optical radiation, which is focused, collimatedand/or directed by the delivery optics 106 to the mask 108. The mask 108can be placed on a target area of a patient's skin, and may provide adamage pattern on the target area of the skin with a fill factor in therange from 0.1% to 90%. The fill factor is the percentage of the targetarea exposed to the EMR that is emitted by the EMR source 106.

In one exemplary embodiment, the EMR source 106 is one of a laser, aflashlamp, a tungsten lamp, a diode, a diode array, and the like. Inanother exemplary embodiment, the EMR source 106 is one of a CO₂ laserand a Er:YAG laser.

Prior to being used in a dermatological treatment, the system 100 shownin FIG. 1A can be configured by a user. For example, the user mayinterface with the control module 102 in order to specify the specificsettings usable for a particular procedure. The user may specify thewavelength of the EMR, the energy delivered to the skin, the powerdelivered to the skin, the pulse duration for each EMR pulse, thefluence of the EMR delivered to the skin, the number of EMR pulses, thedelay between individual EMR pulses, the beam profile of the EMR, andthe size of the area within the mask exposed to EMR. The EMR source 104may be set to produce a collimated pulsed EMR irradiation with awavelength ranging from 400 to 11,000 nm, and preferably near 3.0 μmwhen using an Er:YAG laser and near 10.6 μm when using a CO₂ laser asthe EMR source. The collimated pulsed EMR irradiation may be appliedwhich has a pulse duration in the range of 1 μs to 10 s, preferably inthe range of 100 μs to 100 ms, and more preferably in the range of 0.1ms to 10 ms, and fluence in the range from 0.01 to 100 J/cm², andpreferably in the range from 1 to 10 J/cm². The applied EMR should beable to achieve at least a temperature rise within the exposed areas ofthe skin that is sufficient to cause thermal damage to the epidermis 110and/or the dermis 112. The peak temperature sufficient to cause thermaldamage in the exposed tissues is time dependant and at least in therange of 45° C. to 100° C. For exposure times in the range of 0.1 ms to10 ms the minimum temperature rise required to cause thermal damage isin the range of approximately 60° C. to 100° C. The depth of thermaldamage can be adjusted by proper choice of wavelength, fluence per pulseand number of pulses.

During the dermatological treatment, the system 100 produces EMR 120which is directed to the target area of the skin 114, as shown in FIG.1B. The EMR 120 may be pulsed multiple times to create the appropriateaffect and irradiation in the target area of the skin 114.

After the dermatological treatment is completed, the target area of theskin 114 is likely damaged in specific places. The application of theEMR 120 creates a prearranged thermal skin damage 130 in an epidermaltissue 110 and the dermal tissue 112. It should be noted that thethermal skin damage 130 extends through the epidermal tissue 110 andinto the dermal tissue 112 only to a predetermined depth. The mask 108controls in a location where the thermal skin damage 130 is created. Thethermal skin damage 130 generally accounts for only 0.1% to 90% of theskin surface area in the target area. A fill factor is defined as theratio of surface area of the target area of skin thermally damaged byEMR to surface area of the target area of the skin.

In an exemplary embodiment of the present invention, the thermal skindamage 130 may extend through the epidermal tissue 110 and through theentirety of the dermal tissue 112. In another exemplary embodiment ofthe present invention, the thermal skin damage 130 may occur principallyin the dermal tissue 112 and minor skin damage may occur in theepidermal tissue 110. It should be noted that it is possible that thepenetration depths of each of the micro areas of the thermal skin damage130 may be different from one another or same as one another. This maybe because pigment removal or dermal removal can be separately regulatedby varying the density of the micro-damaged areas for either the deeperor superficial damages, e.g., dermal remodeling and pigment adjustment,respectively.

FIG. 2 illustrates a top view of a first exemplary embodiment of themask 108 according to the present invention. The mask 108 includesshielding structured 202. The diameter of the mask 108 should preferablybe matched to greater than the size of the diameter of the target area.The target area is defined as the area targeted by the collimated EMRemitted by the EMR source 104, which can be in the range 1-100 mm indiameter, preferably within the range of 5 to 20 mm. This diameter ofmost of the currently commercially available CO₂ and Er:YAG lasersystems can match the diameter of the exposed area. The width ofshielding structures 202 within the mask 108 should be in the range of50 to 300 μm. The width of the apertures of the mask 108 that are formedby the shielding structures should be in the range of 10-1000 μm, andpreferably in the range of 50 to 300 μm. The shielding-exposure ratiosurface area covered by the of shielding structures 202 to the surfacearea exposed by the apertures effects the clinical efficacy and providesside effects of the dermatological treatment. This also determines thefill factor and the pattern of the thermal damage of the skin. The depthof thermal damage is determined by the number of pulses, the fluence ofthe EMR and the wavelength of the EMR. The shielding-exposure ratio ofthe mask 108 will vary for different dermatological treatments,particular patient needs, particular patient indications, skin types andbody areas.

The mask 108 may have a large shielding-exposure ratio at the edge ofthe mask 108 to generate a transition zone at the edge of resurfacedarea. This technique is called “feathering.” It avoids a sharpmacroscopically visible demarcation between treated and untreated areas.In another preferred embodiment, a mask may be used that has a largeshielding-exposure ratio at the edge of a conventionally resurfaced areato generate a transition zone.

The surface of the mask 108 should preferably have a minimal absorptionat the wavelength generated by the EMR source 104 for the particulardermatological process. Such absorption can decrease the undesirableheating of the mask 108. The mask 108 may be coated by a metal materialfor affectuating a minimal absorption of the EMR. The design of theshielding structures 202 of the mask 108, a cross-section A-A of whichis shown in FIG. 3, generally takes into consideration safety aspects,including a back-reflected EMR in order to avoid EMR inflictedaccidents. The shielding structures 202 are shaped in a peaked manner tominimize the amount of back reflected EMR. Also, with the mask 108 beingconnected to the case 101 the distance between the delivery optics 106and the mask 108 is fixed, thereby minimizing the chances that EMR wouldbe reflected back towards the user by hitting the edge of the mask 108.Additionally, the microstructure of the mask 108 can have a periodicitypreferably in the range of the wavelength of the EMR emitted by thedelivery optics 106. This configuration can diffuse the collimated EMRemitted by the delivery optics 106 into a highly scattered beam so as todecrease the risk of EMR-related accidents.

In one exemplary embodiment, the metal coating of the mask 108 may becomposed of gold, silver, or copper materials, or the like. In anotherexemplary embodiment, the microstructure of the surface of the mask 108may have a periodicity in the range of the wavelength of the EMR emittedby the delivery optics 106.

The mask 108 may also have a configuration so as to provide effectiveskin cooling during the exposure thereof with the EMR radiation. Skincooling provides significant anesthetic effects, and has otheradvantages related to the pattern induced by the EMR radiation. The mask108 can be cooled prior to the beginning of the dermatologicalprocedure, during the procedure by spraying an evaporative agent or aprecooled liquid onto the mask 108 between the successive EMR pulses, orduring the procedure by introducing a cool or cold liquid intomicrochannels 302 (shown in FIG. 3) running through the mask 108. Thecooling of the mask 108 has a secondary advantage in that such coolingof the mask 108 decreases the rate of the EMR absorption by the mask108, as the rate of the EMR absorption by the metals increases with theincreasing temperature.

In order to provide skin cooling as described above, the temperature ofthe mask 108 should be in the range of 37° C. to −20° C., and preferably10° C. to −4° C. The mask 108 can both protect and cool the portions ofthe skin surface that are not exposed to EMR emitted by the EMR source104. In addition to cooling and shielding portions of the skin surface,the mask 108 allows the debris ejected during ablative procedures toescape, and thereby not interfere with the beam delivery for successivepulses. For example, the areas that are not exposed to the laser arebeing cooled by the mask 108, i.e., the areas that are provided betweenthe affected areas. In another exemplary embodiment, all areas (i.e.,both the affected and nonaffected areas) are cooled to provideanesthesia, and to reduce over-damaging the superficial levels of thedamaged areas.

FIG. 3 illustrates a cross-section A-A of the mask 108 of FIG. 2. Thecross-section A-A shows the microchannels 302 that run through at leastthe shielding structures 202 of the mask 108. A cooling agent, e.g.,either a liquid or gas, may circulate through these microchannels 302during a dermatological procedure, thereby removing heat from theprotected skin and the mask 108 itself.

FIG. 4 illustrates a top view of a second embodiment of the mask 400according to the present invention. The mask 400 differs from the mask108 only in the layout and design of the shielding structures 402. Thedetails of the mask 400 are in all other respects substantially similarto those of the mask 108. The shielding structures 402 are cylindricalin shape, as indicated in cut-away cross-sections B-B and C-C, shown inFIGS. 5 and 6, respectively. The shielding structures 402 of the mask400 contain microchannels 502 and 602, which are capable of carrying acooled liquid or gas so as to cool the mask 400 and the masked portionsof the target area of the skin. The microchannels 502, 602 intersect atthe intersection of the shielding structures 402.

In an exemplary embodiment of the present invention, the microstructures502, 602 are not required to intersect at the intersection of theshielding structures 402.

In an exemplary embodiment of the present invention, the mask 108 is anablative mask. An ablative mask includes multiple sections havingvarious thicknesses. Prior to a procedure, the ablative mask is attachedto the skin with an adhesive. During the procedure having multiple EMRpulses, the ablative mask is ablated, such that the thickness of each ofthe multiple sections is diminished, potentially gradually exposingdifferent areas of the skin to the EMR pulses. The ablative mask can becomposed of various materials including polymer materials. The ablativemask can be easily produced by imprinting a pattern therein.

A particular dermatological treatment, i.e., the removal of tattoos,shall be described in further detail. Tattoo removal may be performedwith a combination of an ablative EMR and the mask 108. In particular,utilizing the CO₂ laser and/or the Er:YAG laser may be appropriate forthis application. During this dermatological procedure, the tattoo canbe exposed to ablative EMR radiation with the mask 108 providing a fillfactor of the target area in the range of 10 to 90%, and preferably inthe range of 25 to 70%. Preferably, the mask 108 is applied underpressure to the skin, which minimizes the blood flow during theprocedure. Limiting the blood flow during the procedure allows a deeperablation of the skin surface before blood can interfere with the EMRradiation, thereby limiting the ablation depth. Multiple pulses ofablative EMR radiation can be applied to the individual areas of thetattoo until the desired ablation depth is reached. The desired ablationdepth can be in the range of 100 μm to 5 mm. This exemplary procedurecan cause a specific fraction of the tattoo that is controlled by themask 108 to be immediately ablated. Wound healing may be enhancedbecause only a fraction of the surface is ablated.

The removal of tattoos utilizing fractional resurfacing may be augmentedusing a short pulsed EMR, preferentially absorbed by the tattooparticles either before or after the application of the fractionalresurfacing. In a short pulsed-laser application, the laser may bepulsed for short periods of time, preferably for less than 1 μs induration. The EMR source used in this type of procedure can preferablybe a Q-switched ruby laser, a Nd:YAG laser, a KTP laser and/or anAlexandrite laser. The objective of this procedure is to release thepigment within areas that are not exposed to fractional resurfacingablation. The released pigment particles may drain in the ablatedchannels, and can be flushed from the area after the procedure by theblood resident in the target area and/or an external rinsing agent,e.g., saline. Several such procedures may be utilized until the desiredclearance of the tattoo has occurred.

As an alternative to the fractional resurfacing using a mask, a secondembodiment of a fractional resurfacing system 700, as shown as theprogressive use thereof in FIGS. 7A-7B, can be used. The system 700 caninclude a case 701, a control module 702, an electromagnetic radiation(“EMR”) source 704, delivery optics 706, an x-y translator 708 and anoptically transparent plate 709. The case 701 may contain the controlmodule 702, the EMR source 704, the delivery optics 706 and thetranslator 708. As with the system 100, an aperture may be formedthrough a sidewall of the case 701. The optically transparent plate 709may be placed in registration with the aperture that is formed throughthe sidewall of the case 701. Placing the plate 709 in registration withthe aperture formed through the sidewall of the case 701 seals thesystem 700, which contains sophisticated translation mechanisms, e.g.,the delivery optics 706 and the translator 708. The control module 702is in communication with the translator 708 and the EMR source 704, andthe EMR source 704 is operatively connected to the delivery optics 706.

In one exemplary variant of the present invention, the control module702 can be located outside of the case 701. In another exemplaryvariant, the EMR source 704 is located outside of the case 701. In stillanother variant, the control module 702 and the EMR source 704 arelocated outside of the case 701.

The control module 702 provides application specific settings to the EMRsource 704, and controls the x-y translator 708. The EMR source 704receives these settings, and generates EMR based on these settings. Thesettings can control the wavelength of the energy produced, theintensity of the energy produced, the fluence of the energy produced,the duration of the dermatological procedure, the pulse length of eachof the EMR pulses administered during the procedure, the spatialdistance between individual exposure areas 716 (shown in FIG. 8), theshape of individual exposure areas 716, the pattern defined byindividual exposure areas 716, and the fill factor of the target area.It should be noted that the thermal skin damage caused to individualexposure areas 716 extends through the epidermal tissue 710 and into thedermal tissue 712 only to a predetermined depth. The EMR source 704 canbe a laser or other light source. The EMR produced by the EMR source 704can be delivered through a fiber, waveguide or mirrors if the source islocated outside the delivery optics 706. Alternatively, if the EMRsource 704 is located in a close vicinity to the skin 714, the EMRsource 704 produces the EMR directly to the delivery optics 706. Theenergy produced by the EMR source 704 may be focused and/or directed byfocusing optics in the delivery optics 706 to one of the an individualexposure areas 716, shown in FIG. 8. Each of the individual exposureareas 716 are located within the target area of the skin 714, and arerelatively small compared to the target area of the skin 714. The targetarea of the skin 714 can generally be 1 cm² in size and each of theindividual exposure areas 716 may be 100 μm in diameter.

In an exemplary embodiment of the present invention, the optics of thedelivery optics 706 may contain a beam collimator or focusing optics. Inanother exemplary embodiment of the present invention, the thermal skindamage caused to individual exposure areas 716 may extend through theepidermal tissue 710 and through the entirety of the dermal tissue 712.In another exemplary embodiment of the present invention, the thermalskin damage caused to individual exposure areas 716 may principallyoccur in the dermal tissue 712 and only minor thermal damage may occurin the epidermal tissue 710. It should be noted that it is possible thatthe penetration depths of each of the micro areas of the thermal skindamage caused to individual exposure areas 716 may be different from oneanother or same as one another. This may be because pigment removal ordermal removal can be separately regulated by varying the density of themicro-damaged areas for either the deeper or superficial damages, e.g.,dermal remodeling and pigment adjustment, respectively. In a furtherexemplary embodiment of the present invention, the predetermined depthof the thermal skin damage caused to individual exposure areas 716 isapproximately 300 μm.

Prior to use in a dermatological treatment and similarly to the use ofsystem 100, the system 700, as shown in FIG. 7A, can be configured by auser. In particular, the user interfaces with the control module 702 inorder to specify the specific settings to be used for a particularprocedure. The user may specify the desired damage pattern, thewavelength of the energy produced by the EMR source 704, the intensityof the energy produced, the fluence of the energy produced, the lengthof time the treatment will take and the pulse duration of the EMR source704. During the treatment, the translator 708 moves the delivery optics706 across sequential portions of the target area of the skin 714 inorder to treat the entire target area. The target area is treated whenthe system 700 delivers EMR to individual exposure areas 716 of thetarget area. The individual exposure areas 716 may be targeted seriallyand/or in parallel. When one of the portions of the target area has beencompletely treated, the system 700 is moved to the next portion of thetarget area. For example, the system 700 is moved at the completion ofirradiation of each portion of the target area until the desired skinsurface damage pattern is achieved for the entire area. The system 700can be moved using discrete movements from one sequential portion to thenext, i.e., stamping mode, or using continuous movement across the skinsurface, i.e., continuous scanning mode. In either case, the movement ofthe delivery optics 706, driven by the translator 708, is controlled bythe control unit 702 and likely matched with the movement of the system700 by the operator (or the user) in order to provide the desiredsurface damage pattern to the target area of the skin 714.

In an exemplary embodiment of the present invention, the system 700,while operating in the continuous scanning mode, can deliver EMR to aparticular individual exposure area 716, then, after exposure of sucharea 716, translate along the skin of the target area, and thereafterdeliver a further EMR to another individual exposure area 716 separatedfrom the previous particular individual exposure area 716 bynon-irradiated region. In another exemplary embodiment of the presentinvention, the system 700, while operating in the continuous scanningmode, can deliver EMR to a particular group of individual exposure areas716, for example the top row of individual exposure areas 716 (shown inFIG. 8), then, after exposure of such areas 716, translate along theskin of the target area, and deliver a further EMR to another group ofindividual exposure areas 716, for example the second row of individualexposure areas 716 (shown in FIG. 8), separated from the particulargroup of individual exposure areas 716 by non-irradiated areas.

In an exemplary embodiment of the present invention, the system 700includes a position sensor, which is in communication with the controlmodule 702. The position sensor is capable of sensing the relativevelocity as between the skin 114 and the case 701. The position sensorcan be an optical mouse, wheels, track ball, conventional mouse, and thelike.

In another exemplary embodiment of the present invention, the system 700targets individual exposure areas 716 one at a time. Administering EMRto the individual exposure areas 716 one at a time decreases the amountof pain experienced by the subject. A time period of 50 milliseconds maybe provided between each administration of EMR to each of the individualexposure areas 716. Thereby controlling the amount of pain experiencedby the subject and avoiding bulk heating of the tissue targeted by thesystem 700. In still another exemplary embodiment of the presentinvention, the system 700 targets a predetermined number of individualexposure areas 716 at a time. Limiting the number of predeterminedtarget areas 716 targeted at one time limits the amount of painexperienced by a patient. Targeting a large number of individualexposure areas 716 at one time requires targeting a collectively largearea of skin, which excites many nerve endings simultaneously, thereforecausing the subject a proportionally large amount of pain. Targetingfewer individual exposure areas 716 causes a subject less pain, butcauses a procedure to take longer.

In a further exemplary embodiment of the present invention, the system700 creates individual exposure areas 716 having a separation distancebetween each of the individual exposure areas 716 of approximately atleast 125 μm and at most 500 μm, preferably, the separation distance isapproximately at least 250 μm. In another embodiment, a separationdistance between the individual exposure areas 716 is at least 125 μm.In still another embodiment, a separation distance between theindividual exposure areas 716 is at most 500 μm.

Before the initiation of a dermatological procedure, the opticallytransparent plate 709 can be brought in a direct contact with the skinsurface covering the target area. The optically transparent plate 709can be composed out of any material having good thermal conductivity,and being transparent over a broad range of the visible and nearinfrared spectrum. The plate 709 seals the system 700, which containssophisticated translation mechanisms, and provides cooling to the targetarea of the skin 714. The plate 709 can provide cooling to the targetarea of the skin 714 in two ways: heat conduction and heat convection.Heat conduction transfers heat through the optically transparent plate709 to the case 701, which provides cooling by circulating a coolantagent through the case 701 of the system 700. The entire opticallytransparent place 709 can also be cooled prior to application to thetarget area of the skin 714. Alternatively, heat convection can beutilized for this procedure. An evaporating agent sprayed onto theoptical window or onto a compartment in good thermal contact with thewindow may also be utilized. The delivery of the evaporating agent canbe administered during the procedure between EMR pulses through a valve,which can be controlled by a thermostat with a temperature sensor at theoptical plate.

In one embodiment, of the present invention the optically transparentplate 709 can be composed of sapphire or quartz. In another embodimentof the present invention, the system 700 can be moved multiple timesover the same portion of the skin 714 until the desired fill factor isachieved. In yet another embodiment, multiple procedures can beperformed to achieve the desired effect.

During the dermatological procedure, the EMR source 704 emits EMR havinga wavelength in the range of 400-12,000 nm. Preferably the EMR has awavelength in one of the following ranges: 1,300 to 1,600 nm, 1,850 to2,100 nm, 2,300 to 3,100 nm and around 10,640 nm. Depending on theapplication, a single wavelength or a combination of differentwavelengths may be utilized. The EMR source 704 can be a diode laser, afiber laser, a solid state laser, a gas laser, and the like. The pulseduration can range from 100 μs to 100 ms, and preferably in the rangefrom 500 μs to 15 ms, and more preferably in the range from 1.5 ms to 5ms. The energy density per pulse within an individual exposure area 716may be in the range of 0.1 to 100 J/cm², preferably 1 to 32 J/cm², andmore preferably 1.5 to 3 J/cm². The energy per pulse within anindividual exposure area 716 may be in the range of 1 mJ and 10 mJ, andpreferably 5 mJ.

In an exemplary embodiment of the present invention, the EMR source 704is a 1.5 μm laser system, preferably a Reliant FSR prototype,manufactured by Reliant Technologies, Palo Alto, Calif., is used.

After the dermatological treatment is completed, the target area of theskin 714 is damaged in a specific pattern. The application of EMRcreates the thermal skin damage in an epidermis 710 and a dermis 712 ofthe skin 714. The radiation provided by the EMR source 704 is deliveredto the skin 714 within multiple small individual exposure areas 716,shown in FIG. 7B, through the delivery optics 706. The delivery optics706 can deliver multiple individual beams across the target area of theskin surface.

FIG. 8 illustrates a top view of the small individual exposure areas 716of the epidermis. The shape of the individual exposure areas 716 may becircular (shown in FIG. 8), elliptical, rectangular, linear or irregularwith a lateral diameter of the smallest dimension in the range of 1-500μm. The fill factor of the target area can be approximately 20-40%.

The system 700 can create multiple individual exposure areas 716 throughheating, ablation, removal, photothermal coagulation, thermal necrosisand/or stimulation. The multiple areas can be exposed sequentially orsimultaneously. Sequential exposure may be achieved by scanning ormoving an energy source which may be either pulsed, shuttered orcontinuous. Simultaneous exposure can be achieved, for example, by anarray of sources or a multi-array of lenses. The array of sources may bea uni-dimensional array, a bi-dimensional array or the like. The arraycan be moved relative to the skin, and one or multiple passes oftreatment can be performed in a target area.

FIG. 9 illustrates an exemplary embodiment of a monitoring system 900according to the present invention. The monitoring system 900 tracks themovement of the system 700, and feeds such positional information to thecontrol module 702. The control module 702 utilizes this information toappropriately instruct the translator 708 to position the deliveryoptics 706, such that the appropriate damage pattern is achieved acrossthe target area of the skin 714. The monitoring system 900 may use acomputer 902, a mouse 904, and a charge coupled device (“CCD”) camera906. In particular, the computer 902 receives the positional informationabout the system 700 from the CCD camera 906. The computer then updatesthe control module 702 based on this positional information as to thecurrent position of the system 700. The control module 702 utilizes thisinformation to cause the system 700 to create the appropriate damagepattern on the skin 714 within the target area. In addition, themonitoring system can utilize additional motion detecting devices,including, wheels or any other motion sensor.

The shape of the individual exposure areas 716 and the relative patternrepresented by all of the individual exposure areas 716 may vary. Theindividual exposure areas 716 can have a circular, elliptical,rectangular, linear or irregular shape. The average distance betweenindividual regions of exposed skin surface may be in the range between10 to 2000 μm, and preferably in the range of 100 to 500 μm. Themacroscopic pattern of the individual exposure areas 716 may be a fieldof uniformly distributed individual exposure areas 716 with constantspacing throughout the target area, randomly distributed individualexposure areas 716 within the target area, and/or regularly distributedindividual exposure areas 716 with constant average spacing withrandomly shifted location. In particular, having regularly distributedindividual exposure areas 716 with constant average spacing withrandomly shifted location may be useful to minimize undesirable effects,which may occur during multiple treatments. Such multiple treatments areutilized to cover the entire area as homogeneously as possible by theindividual exposure areas 716 during the course of multiple treatments.However, uniformly distributed individual exposure areas 716 withconstant spacing throughout the target area may create unwanted spatialdistributions similar to moiré patterns, resulting in spatialinterference macroscopic patterns generated with a distance in betweenthe areas of exposure which have a significant spatial period. In orderto minimize the occurrence of moiré patterns, a randomized shift withinthe range of 10 to 50% of the average distance between individualexposure areas 716 during a single scan may be utilized.

The treatment can be performed in by a single treatment covering theskin surface with a specific surface damage pattern, or by multipletreatments either performed at the same visit or during differenttreatment visits. Individual or multiple exposures can be used toachieve the appropriate thermal damage in particular individual exposureareas 716.

Fractional resurfacing may cause portions of the epidermis to bethermally damaged or ablated, thereby reducing the efficacy of thebarrier function of the epidermis and in particular decreasing thestratum corneum. This facilitates the delivery of drugs or specificsubstances to the dermis and epidermis which can either enhance theeffects of the treatment, or decrease the side effects caused by partialdamage of the epidermis and/or dermis. Groups of drugs and substances,which may enhance the efficacy of skin remodeling include growthfactors, collagen byproducts, collagen precursors, hyaluronic acid,vitamins, antioxidants, amino acids and supplemental minerals amongothers. Groups of drugs and substances, which may decrease side effects,can be steroidal anti-inflammatory drugs, non-steroidalanti-inflammatory drugs, antioxidants, antibiotics, antiviral drugs,antiyeast drugs and antifungal drugs.

In an exemplary embodiment of the present invention, the vitamins thatare used may be vitamin C and/or vitamin E. The supplemental mineralsused are copper and zinc. The antioxidants can be vitamin C and/orvitamin E.

In a clinical observation, enhanced wound healing was observed forfractional resurfacing as compared to conventional resurfacing. Theforearm skin of a white, male Caucasian was exposed to pulsed CO₂ laserradiation with identical settings of the illuminating laser beam with abeam diameter of approximately 3 mm, a Coherent Ultra Pulse Laser, CPGhandpiece, at approximately 300 mJ/pulse. One area was exposed to thelaser beam without benefit of a mask while another area was partiallyshielded by a cooled mask. More pronounced erythema was evident at theconventionally resurfaced test site as compared to the fractionallyresurfaced test site.

The fill factor of the target area may be monitored by sensing theelectrical impedance of the skin from a location on the skin within thetarget area to a remote location on the skin outside of the target areaduring or after treatment. An indicator capable of staining the defectsin the stratum corneum (for example, trypan glue) or transdermalwaterloss are effective indicators of the fill factor of the targetarea.

The foregoing merely illustrates the principles of the invention.Various modifications and alterations to the described embodiments willbe apparent to those skilled in the art in view of the teachings herein.It will thus be appreciated that those skilled in the art will be ableto devise numerous techniques which, although not explicitly describedherein, embody the principles of the invention and are thus within thespirit and scope of the invention.

1-109. (canceled)
 110. An apparatus for treating dermatologicalconditions, comprising: an energy source arrangement configured toprovide an electromagnetic radiation; an optical arrangement configuredto (i) cause an irradiation of at least one first section of a targetarea of skin with at least a portion of the electromagnetic radiation,and (ii) prevent at least one second section of the target area of theskin from being exposed to at least the portion of the electromagneticradiation; wherein at least one of the energy source arrangement or theoptical arrangement configures the radiation to at least one ofthermally damage or ablate the at least one first section of the skinextending from a surface of the skin to a particular depth within thedermis, and wherein at least one of the energy source arrangement or theoptical arrangement causes a width of the at least one second section ofthe target area to be at least 50 μm in width and at most 300 μm inwidth.
 111. The apparatus of claim 110, wherein the energy sourcearrangement is an ablative laser.
 112. The apparatus of claim 110,wherein the energy source arrangement is a carbon dioxide laser. 113.The apparatus of claim 110, wherein the energy source arrangement is aEr:YAG laser.
 114. The apparatus of claim 110, wherein the opticalarrangement prevents at least 0.1% of the target area from being exposedto at least the portion of the electromagnetic radiation.
 115. Theapparatus of claim 110, wherein the optical arrangement prevents at most90% of the target area from being exposed to at least the portion of theelectromagnetic radiation.
 116. The apparatus of claim 110, wherein theoptical arrangement includes a masking arrangement which is configuredto mask at least one the portion of the at least second section of thetarget area such that the electromagnetic radiation is prevented fromaffecting the of the at least second section of the target area. 117.The apparatus of claim 110, further comprising a case having an apertureformed in a sidewall of the case, wherein the case contains the opticalarrangement, and wherein at least one of the optical arrangement is inregistration with the aperture.
 118. The apparatus of claim 110, whereinthe optical arrangement comprises a beam collimator.
 119. The apparatusof claim 110, wherein the optical arrangement comprises opticscomponents.
 120. The apparatus of claim 110, wherein the width of the atleast one second section of the target area is formed by a shortestdistance between edges of neighboring ones of exposed areas in the atleast one first section of the target area.
 121. The apparatus of claim110, wherein a percentage of the target area of the skin that is exposedto the electromagnetic radiation is between 20% and 40%.
 122. Anapparatus for treating dermatological conditions, comprising: an energysource arrangement configured to provide an electromagnetic radiation;an optical arrangement configured to prevent at least one portion of atarget area of skin from being exposed to at least a portion of theelectromagnetic radiation; wherein at least one of the energy sourcearrangement or the optical arrangement configures the radiation to atleast one of thermally damage or ablate a region of the skin extendingfrom a surface of the skin to a particular depth within the dermis, andwherein at least one of the energy source arrangement or the opticalarrangement causes a width of the portion of the target area to be atleast 50 μm in width and at most 300 μm in width.
 123. An apparatus fortreating dermatological conditions, comprising: an energy sourcearrangement configured to provide an electromagnetic radiation; anoptical arrangement configured to (i) provide the electromagneticradiation to a plurality of exposure areas on a surface of a skin, and(ii) cause the exposure areas to be separate from one another such withat least one portion of the surface of the skin is unexposed to at leasta portion of the electromagnetic radiation; wherein at least one of theenergy source arrangement or the optical arrangement configures theradiation to at least one of thermally damage or ablate exposure areasextending from the surface of the skin to a particular depth within thedermis, and wherein at least one of the energy source arrangement or theoptical arrangement causes an average distance between nearest edges ofindividual ones of the exposure areas to be between about 100 μm andabout 500 μm.
 124. The apparatus of claim 123, wherein a smallestdimension of the exposure areas along the skin surface is between about1 μm and about 500 μm.
 125. The apparatus of claim 123, wherein theoptical arrangement is configured to expose a percentage of the exposurearea to the electromagnetic radiation that is between 20% and 40%. 126.The apparatus of claim 123, wherein the portion of the electromagneticradiation that is unexposed to the electromagnetic radiation has a widthof about 100 μm and about 500 μm between the nearest edges of theindividual ones of tho exposure areas.